FDA completes drug list for pediatric oversight

The U.S. Food and Drug Administration (FDA) has finalized a list of 400 drugs for which the agency is requiring manufacturers to provide safety and efficacy information concerning pediatric use, done as part of the FDA Modernization Act of 1997.

According to the FDA protocol, the list includes drugs prescribed to children at least 50,000 times a year, or those that fall into a class or category of drugs that either need pediatric indications or have shown improvement over standard therapies.

New or newly indicated drugs can be given a six-month marketing exclusive for manufacturers complying in full. The list can be reviewed at http://www.fda.gov/cder/pediatric. n